A Phase I Dose Escalation Study of LBH589 in Combination With Imatinib Mesylate for Patients With Chronic Myeloid Leukemia in Cytogenetic Remission With Residual Disease Detectable by Q-PCR
- To determine the safety and tolerability of LBH589 given in combination with imatinib
mesylate in CML patients who are in Major Cytogenetic Remission (MCR) with residual
BCR-ABL positive cells after at least 1 year of daily imatinib mesylate treatment.
- To determine the maximum tolerated dose (MTD) and dose-limiting toxicity of LBH589
given in combination with imatinib mesylate in CML patients.
- To study the effect of LBH589 given in combination with imatinib mesylate on
cytogenetic response status and BCR-ABL levels in CML patients in major cytogenetic
remission on imatinib mesylate treatment.
- To study the effect of LBH589 given in combination with imatinib mesylate on residual
BCR-ABL positive primitive progenitors in CML patients in major cytogenetic remission
on imatinib mesylate treatment.
OUTLINE: This is dose-escalation study of panobinostat.
Patients receive oral panobinostat once daily on days 1, 3 and 5; 8, 10, and 12; 15, 17, and
19; and 22, 24, and 26. Patients also receive oral imatinib mesylate once daily on days
1-28. Treatment repeats every 21 or 28 days for up to 4 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 month and then every 3
months for up to 1 year.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of histone deacetylase inhibitor LBH589 in combination with imatinib mesylate
Ravi Bhatia, MD
City of Hope Medical Center
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|City of Hope Medical Center||Duarte, California 91010|
|South Pasadena Cancer Center||South Pasadena, California 91030|